The sales force training ended months ago. Now the salesmen have to convince doctors to prescribe it. AZN has to get Movantik on the preferred formularies and eliminate the need for prior authorization. If that happens, AZN needs to convince consumers to use it daily and not just as needed.
What would really help is a large, secondary, illegal diversion market.
The $3M Q1 sales represents stocking by pharmacies. It's not like Movantik sales fell off a cliff in Q2. On the other hand, $1M Q2 sales is quite underwhelming. You might call it Afrezza-like sales.
RSO common trades at 18%+ yield, which indicates divi is at high risk. RAS is in the 13% range, high but not ridiculous.
But placebo isn't the standard of care. Doc's will be more interested in how NX-1207 performs against other treatments. It might get approved based on these results, but don't expect much in sales.
Writer had it marked as a "can't miss" investment in the mid $15's. He saw nothing but blue skies in KLIC's sales projections. KLIC is down over 30% since on slowing business. Imagine what a real downturn might do. The old-timers on this board know the business much better than the newbie "professionals".
Until proven otherwise, KLIC remains the canary in the coal mine for the chip equipment biz.
The filing will only be for the subset, not the entire Phase 3 treatment group. Sales may reach $50M/year in the EU by the end of the decade, provided a better treatment option doesn't come along.
Stock is down 50% AH.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced regulatory updates from its interactions with the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) regarding a potential path toward marketing authorization for vosaroxin as a treatment for acute myeloid leukemia (AML) in Europe and the United States.
With respect to the United States, after conducting additional safety and efficacy analyses, the company recently met with the FDA. In light of not reaching statistical significance on the protocol-defined primary analysis of overall survival, Sunesis was informed that the Agency did not support a filing and encouraged the company to provide additional clinical evidence to support a future NDA submission.
At 7 AM this morning, EXEL announced that cabo met its primary endpoint for treatment of late stage renal cancer. Stock doubles in premarket. At 8 AM, BMY announces that its Opdivo Phase 3 for late stage renal cancer was stopped early for superior efficacy. A big slug of potential cabo sales just disappeared. So did the EXEL stock price run-up.
It's a competitive world out there.
The housing business is highly cyclical. Construction loans in particular are very high risk. I much prefer the steady life insurance and cemetery businesses, both of which did well last quarter. Wonder if they could bundle them, buy a life insurance policy and get a discount coupon on a cemetery plot. Hoping for a continuation, which includes a reduction in construction loan biz.
December, at ASH. There might be some new data in an ASH abstract prior. Of course, a PR announcing a serious AE could happen at any time.
Symptomatic of why Yahoo is an also-ran in the internet biz. As if the quality of the Finance message board "improvements" and the responsiveness of the software crew wasn't evidence enough.
This is a topical small molecule sodium channel blocker. It just failed a Phase 2 for OA of the knee, which doesn't seem its most likely target.
Teva Pharmaceutical Industries Ltd. (TEVA) (TEVA) and Xenon Pharmaceuticals Inc. (XENE) reported today top line results from the double-blind, placebo-controlled Phase 2b study designed to evaluate the safety and efficacy of topically applied TV-45070 (4% and 8% w/w ointment) in patients with chronic pain due to osteoarthritis (OA) of the knee.
TV-45070 is a small molecule inhibitor of the sodium channel Nav1.7 and other sodium channels, including those that are expressed in the pain-sensing peripheral nervous system. Results from this trial showed that TV-45070 4% and 8% did not demonstrate statistically significant difference from placebo in efficacy endpoints of reductions in pain due to OA.
"While we are disappointed that the Phase 2b trial top-line results did not indicate efficacy in OA, Teva and Xenon have always been committed to a broad development plan for TV-45070 in both nociceptive and neuropathic pain," said Dr. Simon Pimstone, Xenon's President and Chief Executive Officer. "The Phase 2b trial in PHN being conducted by Teva is progressing as planned, and we look forward to seeing top-line results from that trial in the second half of 2016.
The Phase 2b osteoarthritis trial of TV-45070 was a randomized, double-blind, placebo-controlled study conducted at approximately 40 clinical sites across the US. There were three arms in the study and a total of 389 patients were randomized on a 1:1:1 basis: experimental TV-45070 4% administered twice per day; experimental TV-45070 8% administered twice per day; and placebo comparator (matched ointment without TV-45070) administered twice per day. Patients were eligible to participate in the trial if they were 40-85 years of age, had primary OA in a single knee (target knee), and met pre-specified visual analog scale (VAS) pain scores and were otherwise medically healthy. The primary endpoint of the Phase 2b trial was to evaluate the efficacy of four weeks of topical administration of TV-45070 (4% and 8% ointment) compared with placebo
AF confirms in article today. Search for "MannKind's Afrezza Lags Behind Biggest Failure in Inhaled Insulin". I wonder what sort of alternative universe the Manniac's live in.